Medical instrument package



v- 21, 1967 J. L. ARMENTROUT ETAL 3,353,664

MEDICAL INSTRUMENT PACKAGE Filed Aug. 29, 1966 ATTORNEY United States Patent 3,353,664 MEDICAL INSTRUMENT PACKAGE James L. Armentrout, Pasadena, and Pierre Vanat, Glendale, Calif., assignors to Pharrnaseal Laboratories, Glendale, Calif., a corporation of California Filed Aug. 29, 1966, Ser. No. 575,837 Claims. (Cl. 206--63.2)

ABSTRACT OF THE DISCLOSURE A hypodermic syringe package formed of a thermoplastic bubble panel with a flange peelably secured to a metal foil cover layer. A preformed groove in the flange through which sterilizing gases can enter is spanned by the foil cover layer. A pair of pull tabs connect to the bubble panel and the cover layer with one of the pull tabs removable from the package and marked with control data.

This invention relates to a package for a sterile medical instrument and more particularly to an improved blistertype package.

Blister-type packages are used to package a variety of items from stove bolts to masking tape. They are comprised essentially of a thermoplastic film formed with a bubble or blister to hold the item. A ledge surrounding the blister is sealed between two stiff cardboard sheets adhesively bonded together with one of the sheets having a hole for the blister. These cardboard sheets are ripped apart to open the package and they often tear unevenly, leaving ragged edges.

In packaging sterile medical instruments there are many problems involved that do not relate to a simple package for a bolt or screw in a hardware store. The package must be easy to open and not leave exposed unsterile ragged edges which can contaminate a medical instrument as it is withdrawn from the package.

We have provided an easy opening package in which the nurse or physician simply peels back a flexible cover member which stays in one piece. The cover member has a metallic nonfibrous layer which peels easily from a fiat ledge surrounding the blister. The metallic layer leaves no fibers sticking to the flat ledge that might contaminate the encased sterile medical instrument. The metallic layer, however, is impervious to sterilizing gases. To overcome this problem, we have provided a unique vent system for use with the medical instrument package and its cover member.

Once the package is opened and the medical instrument used, hospitals must have a record of it for inventory purposes and to guard against pilferage. We have provided a unique control card integral with the syringe package.

These and other aspects of our invention will become more apparent with reference to the accompanying drawings, in which:

FIGURE 1 is an exploded side elevational view of a medical instrument package showing a hypodermic syringe contained therein;

FIGURE 2 is a bottom plan view of the medical instrument package;

FIGURE 3 is a side elevational view of the medical instrument package showing it open for ready access to a hypodermic syringe;

FIGURE 4 is a right end elevational view of the medical instrument package before it is opened; and

FIGURE 5 is a top plan view of a detached control card.

\Vith reference to the drawings, the medical instrument package is comprised of a thermoplastic sheet 1 with a blister or bubble 8 formed therein. A medical instrument,

3,353,664 Patented Nov. 21, 1967 for example a hypodermic syringe 30, fits inside blister 8 and a cover member 20 is sealed to a fiat ledge 9 by an adhesive 90. A large dome-shaped portion 2 of the blister receives a flange of the syringe and an elongated channel portion 3 receives the syringe barrel and attached needle.

An operator opens the package by grasping tabs 25 and 50 which are not sealed to each other. He then peels cover member 20 back from ledge 9.

A very critical part of the medical instrument package is a cover member that will peel back easily and consistently without leaving exposed unsterile edges. Paper or cardboard cover members bonded directly to ledge 9 tend to tear unevenly with ragged fibrous edges. This makes it difficult to make a sterile transfer from the package without the instrument touching the unsterile ragged edges.

In our invention, we have overcome this problem by providing a metallic, nonfibrous surface bonded directly to thermoplastic ledge 9. This surface can be part of an inner flexible metallic layer 22, as aluminum, permanently bonded to an outer flexible paper or fibrous layer 21. The fibrous layer 21 can be printed with instructions. When an operator peels back the cover member it remains in one piece and separates smoothly and cleanly from ledge 9. There is no chaff or paper fibers from the metallic layer that can fall onto the medical instrument.

The metallic layer 22 provides a cover member that is very easy to peel back but it does create other problems. A metallic layer 22 is impervious to sterilizing gases and the package could explode or crush when subjected to vacuum and pressure in a gas sterilizer. To overcome this problem and insure the sterilizing gases can enter the sealed package, a polypropylene vent cord 41 is sealed within a transverse preformed channel 40 in ledge 9 by cover member 20. A longitudinal channel 42 connects transverse channel 40 with an interior of blister 8.

We have found that a woven polypropylene cord used as a sealed-in vent has unexpected advantages. The polypropylene woven cord does not wet and act as a Wick as does a cotton cord. We have even submerged our package in water with no indication of the polypropylene vent cord drawing liquid into the package. This provides a safety advantage should water accidentally be splashed onto the package.

The sterile medical instrument can be removed from the package in either of two ways. In the preferred Way, the operator peels back the cover member 20. Then he grasps the thermoplastic sheet 1 and bends it back as best shown in FIGURE 3. The blister 8 of the thermoplastic sheet 1 has a transverse interruption in an outer surface of its elongated channel portion 3 about which the thermoplastic sheet buckles. Preferably, the crease or groove 4 extends as a bulge inside channel portion 3 to hold the medical instrument. This opening procedure shown in FIGURE 3 can be used to transfer the sterile instrument to a sterile surface without contaminating the instruments outer surface.

In emergencies, an operator can also open the package without peeling back cover member 20. He does this by grasping the package and quickly bending the thermoplastic sheet backwards about interruption 4, as shown in FIGURE 3. The medical instrument being stiff will then poke a hole through cover member 20 through which the instrument can be removed.

After the operator has opened the package, he tears off tab 50 which also serves as a control card bearing indicia 51 used to control inventory. The detached tab 50, FIGURE 5, is sent to a hospitals central supply section and shows that in this instance a 3 cc. syringe with an 18- gauge needle 1 /2 inches long has been used. By tabulating the many control cards, a hospital knows which sizes they are in need of and can reorder. A hospital can also require a nurse to turn in a control card for each new syringe issued, and thus guard against pilferage. Tab 50 is connected with a flange portion surrounding blister 8 at a weakened or perforated section 52 which is strong enough to keep the tab 50 attached when peeling back cover member 20. However, tab 50 can be separated by grabbing the flange and tab adjacent weakened section 52 and tearing it transversely from flange 9 of the thermoplastic sheet 1.

In the above specification we have used specific examples to describe our invention. It is understood that ordinary persons skilled in the art can make certain modifications to these examples without departing from the spirit and scope of this invention.

We claim:

1. A sterile instrument package comprised of: a gas impervious lower panel of thermoplastic film with a bubble formed therein which has an elongated stern portion and a laterally enlarged head portion; said lower panel having a flange surrounding the bubble with an outer edge of said flange generally following the contour of the bubble to provide a flange of approximately constant width across a transition zone between the enlarged head portion and the stern portion of the bubble; a cover member comprised of a lamina of a gas impervious metal foil and a backing sheet, said metal foil being bonded to the flange by a peelable adhesive with the cover member peeling smoothly across the generally constant width flange adjoining the transition zone in the bubble; said flange having a preformed groove extending between an outer edge and an inner edge of the flange with the metal foil of said cover member spanning the preformed groove in the flange to provide a vent for sterilizing gases to enter; a pair of pull tabs connected to said cover member and said flange, which pull tabs are unsealed to each other at least along a portion of their opposed facing sur- 3 2. A sterile instrument package as set forth in claim 1 wherein the package has a woven polypropylene cord in the preformed groove.

3. A sterile instrument package as set forth in claim 5 1 wherein the backing sheet is paper.

10 terior.

5. A sterile instrument package as set forth in claim 1 wherein the preformed groove extends transversely across the instrument package and the package has longitudinal communication means between the groove and the 15 bubbles interior.

References Cited UNITED STATES PATENTS 2,248,578 7/1941 Moore 2293.5 2,796,982 6/1957 Volckening 20647 X 2,874,836 2/1959 Wertepny 206-78 2,892,538 6/1959 Middleton et al. 206-78 X 2,895,475 7/1959 Cole. 2,947,415 8/1960 Garth 20663.2 2,963,150 12/1960 Dgetluck 206-'78 3,035,691 5/1962 Rasmussen etal. 206-63.2 3,084,793 4/ 1963 Pitman 206-632 3,152,694 10/ 1-964 Nashed ct a1. 206- 632 FOREIGN PATENTS 551,636 2/1957 Belgium.

613,023 1/1961 Canada. 967,171 8/ 1964 Great Britain.

r JOSEPH R. LECLAIR, Primary Examiner. THERON E. CONDON, Examiner.

I. M. CASKIE, Assistant Examiner. 

1. A STERILE INSTRUMENT PACKAGE COMPRISED OF: A GAS IMPERVIOUS LOWER PANEL OF THERMOPLASTIC FILM WITH A BUBBLE FORMED THEREIN WHICH HAS AN ELONGATED STEM PORTION AND A LATERALLY ENLARGED HEAD PORTION; SAID LOWER PANEL HAVING A FLANGE SURROUNDING THE BUBBLE WITH AN OUTER EDGE OF SAID FLANGE GENERALLY FOLLOWING THE CONTOUR OF THE BUBBLE TO PROVIDE A FLANGE OF APPROXIMATELY CONSTANT WIDTH ACROSS A TRANSITION ZONE BETWEEN THE ENLARGED HEAD PORTION AND THE STEM PORTION OF THE BUBBLE; A COVER MEMBER COMPRISED OF A LAMINA OF A GAS IMPERVIOUS METAL FOIL AND A BACKING SHEET, SAID METAL FOIL BEING BONDED TO THE FLANGE BY A PEELABLE ADHESIVE WITH THE COVER MEMBER PEELING SMOOTHLY ACROSS THE GENERALLY CONSTANT WIDTH FLANGE ADJOINING THE TRANSITION ZONE IN THE BUBBLE; SAID FLANGE HAVING A PREFORMED GROOVE EXENDING BETWEEN AN OUTER EDGE AND AN INNER EDGE OF THE FLANGE WITH THE METAL FOIL OF SAID COVER MEMBER SPANNING THE PREFORMED GROOVE IN THE FLANGE TO PROVIDE A VENT FOR STERILIZING GASES TO ENTER; A PAIR OF PULL TABS CONNECTED TO SAID COVER MEMBER AND SAID FLANGE, WHICH PU TABS ARE UNSEALED TO EACH OTHER AT LEAST ALONG A PORTION OF THEIR OPPOSED FACING SURFACES, WITH ONE OF SAID PULL TABS BEARING CONTROL INDICIA AND BEING SEPARATE FROM THE PACKAGE TO SHOW WHAT PARTICULAR INSTRUMENT HAS BEEN USED. 